Many active pharmaceutical compounds may only be beneficially employed within very specific dosage ranges, with ineffective or even deleterious effects being encountered if too high or too low a dosage is employed. Accordingly, it is necessary that such compounds be formulated in a uniform manner such that a consistent dosage of such active compound can be readily manufactured and administered.
Particular problems exist with respect to the formulation of actives which are in the form of liquids. One method typically employed involves blending liquid actives with excipients employing wet granulation techniques wherein such ingredients are utilized in the form of a wet paste. The paste is blended with the pharmaceutically active liquid, and the mixture then dried, ground and tableted. However, such wet granulation processes are disfavored by the pharmaceutical industry because they are labor intensive, require special equipment and are highly susceptible to contamination.
Another, more economical, approach which may be employed is to first absorb the liquid active onto an absorbent material and then dry blend the absorbent/active material with powdered excipient and directly form tablets therefrom. However, because of the low levels of the absorbent/active material incorporated and the fine particle size thereof uniform blending is exceptionally difficult, and separation of the absorbent/active material from the excipient mass can occur during the granulation, blending and/or tableting process with the result that the manufactured products do not meet uniform assay requirements.
A third approach which may be employed to minimize the segregation problem, involves encapsulating such actives in gelatin or other film formers. However, such encapsulation may not effectively prevent segregation as in many instances separation may occur upon the grinding or milling of such encapsulates. Moreover, such a process increases the number of formulating steps required and thus involve the incurring of additional expense.
Thus, it would be desirable to possess a pharmaceutical composition which contains a uniform concentration of liquid active material, which composition can be easily and inexpensively manufactured with low risk of contamination.
Accordingly, it is an object of this invention to provide a pharmaceutical composition having a uniform dispersion of liquid active material.
It is a further object of this invention to provide a process for economically preparing a pharmaceutical composition having a uniform dispersion of liquid active material.
The above objects and other additional objects will become more fully apparent from the following description and accompanying Examples.